open or robotic ventral hernia repair outpatient for Ventral Hernias

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Prisma Health, Greenville, SC
Ventral Hernias+4 More
Standard opioid plus methocarbamol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair. Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment. Participants will be randomized into one of the study groups listed below. Primary ventral hernia repair or inguinal hernia repair: Group 1: standard opioid after surgery Group 2: methocarbamol after surgery Open or robotic ventral hernia repair outpatient: Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery Open or robotic ventral hernia repair inpatient: Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge A total of 120 participants will be included in the study. Participation will last for about 30 days after surgery.

Eligible Conditions

  • Ventral Hernias
  • Inguinal Hernias

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 30 days post surgery

30 days post surgery
Average total morphine milligram equivalents (MME) consumption
European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores
Proportion of patients requiring a rescue opioid prescription
7 days post surgery
EuraHS Quality of Life tool scores
Visual Analog Scale pain scores

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

open or robotic ventral hernia repair outpatient
1 of 3
primary ventral hernia repair or inguinal hernia repair
1 of 3
open or robotic hernia repair inpatient
1 of 3
Experimental Treatment

120 Total Participants · 3 Treatment Groups

Primary Treatment: open or robotic ventral hernia repair outpatient · No Placebo Group · Phase 4

open or robotic ventral hernia repair outpatientExperimental Group · 2 Interventions: Standard opioid plus methocarbamol, Standard Opioid · Intervention Types: Drug, Drug
primary ventral hernia repair or inguinal hernia repairExperimental Group · 2 Interventions: Standard Opioid, Methocarbamol · Intervention Types: Drug, Drug
open or robotic hernia repair inpatientExperimental Group · 2 Interventions: Standard opioid plus methocarbamol, Standard Opioid · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methocarbamol
2016
Completed Phase 4
~480

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days post surgery
Closest Location: Prisma Health · Greenville, SC
Photo of Greenville  1Photo of Greenville  2Photo of Greenville  3
2021First Recorded Clinical Trial
2 TrialsResearching Ventral Hernias
18 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients undergoing open primary ventral hernia repair (group 1) are aged 18 years or older.
Repair ventral or incisional hernias.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.